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Phase III Results Lead Aveo and Astellas to Plan Regulatory Submissions for Tivozanib

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Aveo Pharmaceuticals and Astellas Pharma reported positive data from a Phase III trial comparing the investigational tyrosine kinase inhibitor tivozanib with sorafenib in patients with advanced renal cell carcinoma. The firms say they now plan to submit marketing approval applications to FDA and the European authorities, during 2012, subject to final analyses of all data from the trial.

The 517-patient TIVO-1 study was the first registration trial in first-line renal cell carcinoma to compare an investigational agent with an approved VEGF therapy, Aveo notes. Data from the study found that tivozanib led to a median progression-free survival (PFS) of 11.9 months compared with a median PFS of 9.1 months associated with sorafenib. PFS specifically in the 70% of trial patients who were previously treatment naive was 12.7 months for those treated with tivozanib and 9.1 months for those receiving sorafenib.

Tivozanib is an oral, once-daily small molecule drug designed as a selective inhibitor of all three VEGF receptors. The candidate is separately undergoing clinical evaluation as a combination therapy for a range of tumor types including breast, colorectal, and gastrointestinal.

Aveo and Astellas inked their agreement to co-develop tivozanib worldwide (excluding Asia) for a range of cancers in February 2011 with $125 million up front. Under terms of the deal Aveo could receive another $1.3 billion in development and regulatory milestones.

The firm’s other clinical-stage candidate, ficlatuzumab (AV-299), is an anti-HGF/c-MET antibody currently in Phase II development as a combination therapy against non-small-cell lung cancer and is undergoing earlier clinical evaluation in combination therapy against other solid tumors. Ficlatuzumab was discovered by Aveo through its Human Response Platform. It is based on the company’s genetically defined mouse models of human cancer, in which each model is engineered to contain signature genetic mutations that are present in human disease.

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